QA/QC Specialist – Ref: QA/LB/30/11/17 – Lusaka


Application Deadline: December 15, 2017

Reporting to the QA/QC Manager, the Medical Laboratory Technologist (QA/QC Specialist) will be required to provide support to several protocol/research teams. S/he will also work closely with Research Coordinators and bench supervisors in developing procedures and ensuring that all procedures are ready in time for start of any study/research protocol.

 

 

Main Duties

Ensure that Laboratory’s documented policies and procedures are reviewed and are up to date as required. Ensure that all laboratory SOPs are written and maintained as per the writing of quality systems documents and document control procedures. Work with bench supervisors to carry out periodic reviews of documents at the benches to ensure that only valid documents are in circulation. Provide support to the Assistant QA/QC Manager in timely testing and submission of External Quality Assurance samples and compilation of evaluation results to effect instrument to instrument and staff comparison data. Participate in the designing of an internal audit process, including checklists, schedule of implementation, reporting of findings, resolution action plans, implementation of corrective and preventive actions and subsequent documentation. Work with the Assistant QA/QC Manager to collect cumulative quality key indicator data from QC records, analyze and report trends in the QC process that may result in the generation of inaccurate reports or delayed TAT turnaround times, and generate monthly reports on QC trends to report to the QA/QC Manager. Stand in for the Assistant QA/QC Manager in his/her absence and carry out all duties as required. Work with the Research Coordinator in investigations and documentation of corrective and preventative actions, tracking, trending, and maintenance of historical files. Work closely with the Research Coordinator and the protocol team and support new protocols by ensuring that SOPs and other documents required by the protocol teams are approved. Provide necessary over site on the benches to ensure that all protocol related activities are carried out in accordance with respective protocols and regulations. In a number of times the Medical Laboratory Technologist (QA/QC Specialist) will be required to attend protocol/study meetings to represent the QA/QC Manager. Work hand in hand with the Research Coordinator to monitor laboratory testing for all assigned protocols/studies report any deviations to the QA/QC Manager. May be required to perform LDMS reviews, storage verification, discrepancies resolutions, assay applications (DNA & RNA & data exportation). Any other responsibilities as may be assigned by the QA/QC Manager

Qualifications and experience

A Bachelor’s degree in Biomedical Science discipline or recognised equivalence. At least 2 years’ experience with medical laboratory instruments and processes. Or a Diploma in Biomedical Science with At least 3 years experience with medical laboratory instruments and processes. At least 2 years working in a laboratory that involves daily analysis of DAIDS or other related protocol. In-depth knowledge of GCLP and ISO 15189. Mathematical skills, including calculations and statistics. Ability to operate a computer, Microsoft software applications and other equipment necessary to collect and analyze QC data.

Demonstrated leadership/management skills. Demonstrate quality transcription work with little or no errors. Advanced knowledge of laboratory terminology and interpretation of laboratory values. Excellent written and oral communication skills, including grammar, punctuation, and style, to provide consistent quality documents and updates to laboratory management. Proficient in referencing, researching, reporting, tracking, and monitoring. Ability to multi-task with multiple priorities and time frames. Ability to work independently with minimal or no supervision. Possess good organizational skills for file management. Ability to communicate QA concerns/questions effectively with clients, management and all staff.

Suitably qualified candidates are invited to apply; however only shortlisted candidates will be contacted. Please send application letter quoting the reference number above, relevant academic and professional certificates, and detailed CV with day-time telephone number(s) to: CIDRZ Human Resources Director, PO Box 34681, LUSAKA or email: jobs@cidrz.org

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